An interventional study of Teachers Leading the Frontlines and Responding to Students' Emotions Through Education in Child Behavior, Mental Health Issue and Psychosocial Functioning, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 5 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care.
Participants: \~300 estimated
Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
Addressing children's mental health is a critically important health challenge. Twenty percent of all children suffer from significant mental health concerns, most of whom will remain unrecognized, unsupported, and affected throughout their lives. Such wide differences between mental health needs and care access are often called the "care gap". More recently, a youth mental health crisis emerged alongside the COVID-19 pandemic. The adverse impact of the pandemic has led to youth mental health prevalence increasing up to 40% in some global regions, which is double the pre-pandemic rate, while available professional mental health human resources have not changed, leading to an even wider care gap. As urgent solutions are needed, alternative systems of care and support may address this urgent need in a more timely fashion than expanding traditional care systems would.
The overarching goal of this study is to address the youth mental health crisis by providing evidence that high-quality, alternative, sustainable child mental health care may improve youth mental health symptoms. This proposal aims to pilot a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. In North Carolina, USA, the investigators will pilot Teachers Leading the Frontlines - Mansik Swastha [Mental Health in Nepali] (Tealeaf). Created in Darjeeling, India, Tealeaf centers on training and supervising elementary school teachers to deliver "education as mental health therapy" (Ed-MH) to children (ages 5-12). Ed-MH is the investigators' novel, task-shifting, therapy modality that minimizes the time teachers need to deliver care by fitting it into their work. In Ed-MH, teachers use evidence-based therapeutic techniques adapted for use in their existing interactions with students in need (e.g., while teaching) and streamlined for care for any diagnosis ("transdiagnostic").
The investigators' rationale stems from two trials in Darjeeling where the mental health symptoms of children in Tealeaf improved from clinical to neurotypical. The investigators specifically aim to determine if teachers can deliver Tealeaf with fidelity, with positive acceptability \& feasibility for stakeholders, and leading to preliminary indicators of improved child mental health outcomes. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) public health framework, the investigators hypothesize that a pilot of Tealeaf clustered at the school level will show that:
Researchers will compare Tealeaf with an active comparator, RE-SEED (Responding to Students' Emotions through Education), to see if a lower-resourced version of Tealeaf is viable and/or has an impact.
Tealeaf has six components implemented over a school year:
For RE-SEED (active comparator), processes are similar to Tealeaf. The differences are that training is 1-day such that they receive markedly less in-depth knowledge, and the study team does not provide supervision, allowing only the counselor to provide supervision. This less resource-intensive approach will allow for an ethical comparator to Tealeaf, where schools would like for teachers to have some skills to support identified students as part of their willingness to participate in research, while also allowing the investigators to begin to understand what impact fewer resources may have versus a full intervention.
Tealeaf and Ed-MH's mechanism of action for improving mental health symptoms is through teachers guiding children to consistently practice coping skills and emotion regulation for long periods (a school day) and in real-time (in moments of concern). Like counselors, Tealeaf teachers help students gain insight and acquire coping skills. Teachers take the therapy activities further, though, by overseeing children practicing coping skills, reinforcing positive behavior, and supporting them in moments of struggle, all in real-time. It is ideally how teachers would work with students as guided by a therapist, but here they determine how to therapeutically respond to a student's mental health needs since therapists are inaccessible. Moreover, as a role model, teachers already play a key role in the social, emotional, and academic development of students and interact with them individually in moments of concern. Ed-MH allows teachers to deliver therapy in shared moments, in real time. Professional and lay counselors, instead, can only reflect from afar on moments the student is willing to share in the office.
A second mechanism of action is through teachers delivering care that can target education symptoms of mental health as seen in India. For example, a student may have poor schoolwork due to anxiety. Their teacher can target their poor schoolwork (the education symptoms of their mental health) and anxiety by improving schoolwork quality (an education intervention) by building their capacity to complete assignments gradually, i.e. exposure therapy (an evidence-based technique). After care, both symptoms improved.
Intervention evidence: Results from 2018 and 2019 pilot Tealeaf trials show that mental health care delivery for children can be shifted to teachers.
Overall, our prior research demonstrates that teacher-delivered transdiagnostic mental health care (Tealeaf inclusive of Ed-MH) may be a potentially efficient, sustainable, and impactful approach. A Type 1 hybrid effectiveness-implementation Tealeaf trial is ongoing in Darjeeling, India.
The investigators' rationale for pilot testing Tealeaf-NC is based on Tealeaf's promising results as there is an urgent need to identify and deliver evidence-based children's mental health interventions to tackle the children's mental health care gap that worsened into a crisis during the COVID pandemic. Of note, Tealeaf skipped over efficacy (lab-like setting) to effectiveness testing (real world), as literature supports skipping efficacy testing of task-shifted mental health care. Task-shifting improves mental health outcomes in lab-like settings and is now recommended to be tested in specific forms (e.g., teacher-delivery) for specific contexts to study its effects in real-world practice. As research evidence takes an average of 17 years to reach clinical practice, and given Tealeaf's promise, the urgent need justifies pilot testing Tealeaf's potential implementation and clinical outcomes in new settings.
Schools:
Principals:
Teachers:
Counselors:
Students:
Guardians:
Exclusion Criteria:
Teachers in the Tealeaf arm receive in-depth training and regular supervision and coaching from the study team.
Behavioral: Teachers Leading the Frontlines
Teachers in the RE-SEED arm receive much less in-depth training. The study team does not provide supervision allowing only the school counselor to provide supervision.
Behavioral: Responding to Students' Emotions Through Education
1. During 3-day training, Knowledge and attitudes toward child mental health care are measured pre-training, post-training, and post-intervention. 2. The teachers select students whom they believe have the highest mental health needs to receive care. 3. Teachers analyze chosen students' symptoms. 4. Teachers analyze students' behavior with the AABC Chart. 5. Teachers develop a targeted response using a behavior plan called the 4Cs plan (Cause, Change, Connect, and Cultivate). In the 4Cs, teachers select therapeutic techniques to deliver from a menu of evidence-based therapeutic options for each category of behavior. 6. Throughout the year, teachers receive supervision through monthly site visits supplemented by as-needed telephone and digital discussions to guide their care from the study team. Teachers encourage the use of the 4Cs plan at home.
Also known as: Tealeaf
All processes for RE-SEED are the same as in Tealeaf except... 1. Teachers receive only 1 day of training 2. The study team does not provide supervision to the teachers, allowing only the school counselor to provide supervision This less resource-intensive approach will allow for an ethical comparator to Tealeaf, where the schools would like for teachers to have some skills to support identified students.
Also known as: RE-SEED
Mean Acceptability of Intervention Measure (AIM) Scores
The Acceptability of Intervention Measure (AIM) measures the stakeholder's beliefs about the acceptability of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more acceptable, and a score greater than or equal to 4 indicating positive acceptability.
Time frame: Month 0, Month 9
Mean Intervention Appropriateness Measure (IAM) Scores
The Intervention Appropriateness Measure (IAM) measures the stakeholder's beliefs about the appropriateness of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely Agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more appropriate, and a score greater than or equal to 4 indicating the intervention is more appropriate.
Time frame: Month 0, Month 9
Mean Feasibility of Intervention Measure (FIM) Scores
The Feasibility of Intervention Measure (FIM) measured the stakeholder's beliefs about the feasibility of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more feasible, and a score greater than or equal to 4 indicating positive feasibility.
Time frame: Month 0, Month 9
Mean Cause Analysis Chart (AABC) Evaluation Checklist Scores
The Cause Analysis Chart (AABC) Evaluation Checklist is a study-specific tool that assists evaluators in scoring the fidelity with which teachers accurately complete the AABC Chart. Mean scores are calculated and can range from 1 (Needs improvement) to 5 (Advanced) with a higher mean score indicating higher fidelity, and an overall mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
Mean 4Cs Behavior Plan Evaluation Checklist Scores
The 4Cs Behavior Plan Evaluation Checklist is a study-specific tool that assists evaluators in scoring the fidelity with which teachers accurately complete the 4Cs Behavior Plan. Mean scores are calculated and can range from 1 (Needs improvement) to 5 (Advanced) with a higher mean score indicating higher fidelity, and an overall mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
Mean One-on-One Student Interaction Evaluation Tool Scores
The One-on-One Student Interaction Evaluation Tool is a study-specific tool that measures the fidelity with which teachers conduct one-on-one sessions with the student(s). Teachers are rated on six domains on a scale that ranges from 1 (Needs Improvement) to 5 (Advanced). Scores are averaged and rounded to a half point across domains to yield mean scores from 1 to 5 with a mean higher score indicating higher fidelity, and a mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
Mean One-on-One Family Interaction Evaluation Tool Scores
The One-on-One Family Interaction Evaluation Tool is a study-specific tool that measures the fidelity with which teachers conduct family interactions. Teachers are rated on six domains on a scale that ranges from 1 (Needs improvement) to 5 (Advanced). Scores are averaged and rounded to a half point across domains to yield mean scores from 1 to 5 with a mean higher score indicating higher fidelity, and a mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame: Month 9
Change in Strengths and Difficulties Questionnaire Total Difficulties Score
The Strengths and Difficulties Questionnaire is a brief behavioral screening that will measure the mental health of students, and the change in scores will measure the effectiveness of the assigned intervention. The total difficulties score is the summation of 4 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems. Each subscale has 5 items scored as "Not True," "Somewhat True," and "Certainly True" yielding a value of 0,1, or 2. (Some items are scored in reverse). The total difficulties score is generated by summing scores from each scale to yield an overall score. The overall score range is from 0-40, with a higher score indicating more difficulties/worse mental health. A bigger decrease in the total difficulties scores will indicate that the intervention is more effective.
Time frame: Month 0, Month 9
Mean Proportion of Attendance
Using the teachers' and school records, the number of days present will be converted to a proportion of days in attendance (due to the varied length of academic school years). These proportions will be compared between arms, and a higher proportion of attendance will indicate a more effective intervention.
Time frame: Up to 18 months
Change in Academic Achievement
Using the teachers' and school records, a change in student academic achievement score will be coded from available grades, assessment, discipline and IEP/504 information. A significant change in the positive direction will indicate an effective intervention.
Time frame: Up to 18 months
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina (UNC).
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